Chronic PainChronic painNCT07145762
Analgesia Nociception Index In Pediatric Patients With Chronic Pain
An observational study of Chronic Pain, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
The goal of this observational study is to learn about the analgesia nociceptive index (ANI) is associated with pain sensitivity in patients between the ages of 9-17 who are experiencing chronic pain. Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Interventional Block
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 15 Sep 2025to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: All patients who are offered an interventional block at the Edwards Family Interdisciplinary Center for Complex Pain of the Montreal Children's Hospital will be invited to participate. Initial contact will be through the medical team in contact with the patient. They will ask them if they agree to be contacted for a research study. Once the patient consents to be contacted, the research coordinators will reach out the patient and explain the study.
Who may be able to join
- Experiencing chronic pain defined by: persistent or recurrent pain at least once a week for at least three months in their electronic medical charts or by reference of the patient's physician
Who cannot join
- Taking medications known to affect the sympathetic or parasympathetic nervous systems such as cholinomimetics (e.g., pilocarpine), anticholinergics (e.g., ipratropium), sympathomimetics (e.g., salbutamol), and adrenergic antagonists (e.g., propranolol).
- Diagnosed cardiac or neurological conditions, including patients with arrhythmias, heart block, postural orthostatic tachycardia syndrome, Guillain-Barre syndrome, or spinal cord injury.
- Active cancer diagnosis
- Conditions that may interfere with the ability to understand instructions or complete assessments including: cognitive, or developmental delay.
- Patients who do not speak English or French.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Validity of the Analgesia Nociception Index in Children and Adolescents With Chronic Pain
The goal of this observational study is to learn about the analgesia nociceptive index (ANI) is associated with pain sensitivity in patients between the ages of 9-17 who are experiencing chronic pain. The main question it aims to answer is:
- Does the ANI score correlate with the change in the pain sensitivity in patients aged 9-17 undergoing an interventional block.
Patients already receiving an interventional block as part of their regular medical care for chronic pain will have their level of pain recorded during clinic appointments
- Conditions
- Chronic Pain
- Being tested
- Interventional Block
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional BlockProcedure or surgery
For patients who are offered interventional blocks as part of their standard of care, we will measure ANI as well as pressure pain threshold before, during, and after the block as well and at follow-up to assess correlation with treatment efficacy.
| Study group | Role | What they receive |
|---|---|---|
| Chronic pain patients receiving Interventional block | Not described Receives: Procedure: Interventional Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of analgesia nociception index (ANI) as a tool to assess change in the pain pressure threshold (PTT), measured by the PPT test, of children with chronic pain conditions.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start15 Sep 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabrina Carrie, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145762
- Sponsor's protocol ID
- ANI Project
- Acronym
- Chronic pain
- Status last verified
- Aug 2025
- First submitted
- 18 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of the Analgesia Nociception Index in Children and Adolescents With Chronic Pain
- ClinicalTrials.gov ID
- NCT07145762
- Acronym / sponsor ID
- Chronic pain / ANI Project
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn about the analgesia nociceptive index (ANI) is associated with pain sensitivity in patients between the ages of 9-17 who are experiencing chronic pain. The main question it aims to answer is:
- Does the ANI score correlate with the change in the pain sensitivity in patients aged 9-17 undergoing an interventional block.
Patients already receiving an interventional block as part of their regular medical care for chronic pain will have their level of pain recorded during clinic appointments
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic pain patients receiving Interventional block | – | Procedure: Interventional Block |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All patients who are offered an interventional block at the Edwards Family Interdisciplinary Center for Complex Pain of the Montreal Children's Hospital will be invited to participate. Initial contact will be through the medical team in contact with the patient. They will ask them if they agree to be contacted for a research study. Once the patient consents to be contacted, the research coordinators will reach out the patient and explain the study.
Key inclusion criteria (1 listed)
- Experiencing chronic pain defined by: persistent or recurrent pain at least once a week for at least three months in their electronic medical charts or by reference of the patient's physician
Key exclusion criteria (5 listed)
- Taking medications known to affect the sympathetic or parasympathetic nervous systems such as cholinomimetics (e.g., pilocarpine), anticholinergics (e.g., ipratropium), sympathomimetics (e.g., salbutamol), and adrenergic antagonists (e.g., propranolol).
- Diagnosed cardiac or neurological conditions, including patients with arrhythmias, heart block, postural orthostatic tachycardia syndrome, Guillain-Barre syndrome, or spinal cord injury.
- Active cancer diagnosis
- Conditions that may interfere with the ability to understand instructions or complete assessments including: cognitive, or developmental delay.
- Patients who do not speak English or French.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interventional BlockFor patients who are offered interventional blocks as part of their standard of care, we will measure ANI as well as pressure pain threshold before, during, and after the block as well and at follow-up to assess correlation with treatment efficacy. | Procedure or surgery | Chronic pain patients receiving Interventional block |
Primary outcome
Validation of analgesia nociception index (ANI) as a tool to assess change in the pain pressure threshold (PTT), measured by the PPT test, of children with chronic pain conditions.
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabrina Carrie, MD (514-412-4400 ext. 24884, sabrina.carrie@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of analgesia nociception index (ANI) as a tool to assess change in the pain pressure threshold (PTT), measured by the PPT test, of children with chronic pain conditions. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.